Remote Associate Director, Medical Writing

Sarepta Therapeutics; New York (NY); Ibrido; USD 161.000 - 201.000; Tempo pieno

Vantaggi offerti da questo lavoro

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Descrizione del lavoro

Sarepta Therapeutics seeks an experienced Associate Director, Medical Writing to independently plan, develop, and deliver high quality clinical and regulatory documents. You will lead MW strategy, ensure regulatory compliance, and mentor team members in a fast-paced setting.

The role requires extensive experience in medical writing and knowledge of GXP regulations; the position is fully remote within the United States with potential hybrid/onsite events.

Competenze

• Bachelor’s degree or equivalent; life sciences is preferred.
• 10+ years of relevant experience, with 8+ years of medical writing or other writing experience.
• Excellent writing skills.
• Ability to understand, interpret, and communicate clinical and scientific data.
• Knowledge of drug development process and regulatory requirements (GCP/ICH/eCTD).
• Experience with NDAs/BLAs and regulatory documents.

Mansioni

• Plan, prepare, write, edit, format, and finalize clinical and regulatory documents including protocols, study reports, and regulatory submissions.
• Provide product and platform writing and strategy support to cross-functional teams and project teams.
• Lead MW documents ensuring adherence to MW processes and global regulations.
• Collaborate cross-functionally to drive best practices and improvements in trial documentation and readiness.
• Maintain knowledge of regulations, product areas, and current literature; create and maintain SOPs and governance documents.
• Mentor colleagues and support onboarding and training within MW.

Conoscenze

Medical writing

Regulatory writing

Excellent writing

Project management

Cross-functional collaboration

MS Office

Formazione

Bachelor's degree or equivalent; life sciences preferred

Strumenti

MS Office Suite

Descrizione del lavoro

Sarepta Therapeutics seeks an experienced Associate Director, Medical Writing to independently plan, develop, and deliver high quality clinical and regulatory documents. You will lead MW strategy, ensure regulatory compliance, and mentor team members in a fast-paced setting.

The role requires extensive experience in medical writing and knowledge of GXP regulations; the position is fully remote within the United States with potential hybrid/onsite events.